CHICAGO, Feb. 25, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics,
Inc. (Nasdaq:DRTX) today announced preliminary, top-line results
for its DISCOVER 2 ("Dalbavancin for Infections of the Skin
COmpared to Vancomycin at an Early Response") Phase 3 study of
dalbavancin, which is under investigation for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible gram-positive bacteria, including methicillin
resistant Staphylococcus aureus (MRSA).
DISCOVER 2 results follow the recent release of data from DISCOVER
1, which also met its primary and secondary endpoints.

Preliminary top-line data show that dalbavancin achieved its
primary endpoint of non-inferiority (10% non-inferiority margin) at
48-72 hours after initiation of therapy, as determined by the
cessation of spread of the lesion, as well as the resolution of
fever. Researchers were comparing two intravenous (IV) doses of
dalbavancin given one week apart with twice-daily vancomycin doses
for 14 days. Patients randomized to the vancomycin regimen had an
option to switch to oral linezolid after three days of vancomycin
treatment. In addition, the trial assessed as a secondary outcome
measure the non-inferiority of clinical response at the end of
treatment in clinically evaluable patients. Dalbavancin also
achieved this secondary endpoint.

The DISCOVER 2 study was conducted pursuant to a special
protocol agreement (SPA) with the U.S. Food and Drug Administration
(FDA) based on the FDA's Draft Guidance for Developing Drugs for
Treatment of ABSSSI. The protocol for the trial was also designed
based on scientific advice provided by the European Medicines
Agency (EMA).
DISCOVER 2 was a randomized, double-blind, double-dummy trial
conducted in 739 patients at 139 sites in the United States,
Europe, Asia and South Africa comparing dalbavancin to a regimen of
vancomycin (with an option to switch to oral linezolid) for the
treatment of ABSSSI.

1Pre-specified adjustment to the confidence interval by
important baseline variables

In this clinical trial, the drug-related treatment-emergent
adverse event rate for dalbavancin was 12.2% and for
vancomycin/linezolid was 10.1%. The most commonly reported adverse
events for dalbavancin in this trial were nausea, diarrhea,
vomiting, pruritus and headache.
Discontinuations due to treatment emergent adverse events were 2.4%
and 1.9% for dalbavancin and vancomycin/linezolid, respectively.
This adverse event profile is consistent with results from prior
Phase 3 studies and DISCOVER 1. Additional analyses of the data are
ongoing.

"The treatment of serious skin infections remains a challenge
for the healthcare provider," said Mark Wilcox, MD., Head of
Microbiology for the Leeds Teaching Hospitals and Professor of
Medical Microbiology at the University of Leeds, UK. "These
promising results from DISCOVER 2 provide evidence of dalbavancin's
role as a safe and effective treatment option for cellulitis, major
abscess and wound infections while also being more convenient for
patients and potentially more cost-effective for healthcare
systems."

"We are very excited with the positive top-line results of the
DISCOVER
2 trial as they were consistent with all the prior studies done
with dalbavancin," said Durata Chief Executive Officer Paul R.
Edick. "With the completion of both of our Phase 3 studies, we are
on track to submit our NDA with the FDA in mid-year and the MAA
with the EMA at year-end 2013."

Additional information regarding the trial can be found on
clinicaltrials.gov.

Conference Call and Webcast Information

The company will host a conference call today, Monday, February
25,
2013 at 8:30 AM EST. To access the call, please dial 866-632-4021
for participants in the U.S. or Canada and 404-991-3968 for
international callers (reference Conference ID 10797012). A replay
of the call may be accessed through March 11, 2013 by dialing
800-585-8367 for callers in the U.S. and Canada and 404-537-3406
for international callers (reference Conference ID 10797012). The
conference call will also be webcast live at
http://event.on24.com/r.htm?e=585599&s=1&k=6492106EF6010A225EBAAFE767CD
2860.

The webcast will as well be available on the Investor Relations
section of the Company's website at www.duratatherapeutics.com.

About Dalbavancin

Dalbavancin is an intravenous antibiotic product candidate under
investigation for once-weekly dosing, which we believe may
facilitate the treatment of patients with ABSSSI in both the
in-patient and out-patient settings, potentially reducing the
length of a patient's hospital stay or avoiding hospital admission
altogether, with an impact on the overall cost of care for these
patients.

About Durata Therapeutics

Durata Therapeutics is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for
patients with infectious diseases and acute illnesses. Durata has
now completed two global Phase 3 clinical trials with its lead
product candidate, dalbavancin, for the treatment of patients with
acute bacterial skin and skin structure infections, or ABSSSI.

The Durata Therapeutics, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=16463

Forward-looking statements in this press release include
statements about the preliminary top-line results of the DISCOVER 2
trial, the timing of the filing of a New Drug Application with the
U.S. Food and Drug Administration and a Marketing Authorization
Application with the EMA, our estimates regarding the potential
market opportunity for dalbavancin and the potential advantages of
dalbavancin. Actual results may differ materially from those
indicated by these forward-looking statements as a result of
various important factors, including those discussed in the "Risk
Factors" section of our most recent quarterly report on Form 10-Q,
which is on file with the SEC and is also available on our website.
In addition, any forward-looking statements represent our views
only as of today and should not be relied upon as representing our
views as of any subsequent date. While we may elect to update these
forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so, even if our views
change. Therefore, you should not rely on these forward-looking
statements as representing our views as of any date subsequent to
today.